Update on Drugs & Devices: March – April 2020

Trade Name: Tazverik^™
Company: Epizyme, Inc.

Approval Dates/Comments: The US FDA granted accelerated approval of tazemetostat in January 2020 for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection, based on overall response rate and duration of response in a Phase 2 clinical trial. Tazemetostat is the only FDA-approved therapy specifically indicated to treat epithelioid sarcoma patients. It is a first-in-class orally available, small molecule selective and S-adenosyl methionine competitive inhibitor of histone methyl transferase EZH2, with antineoplastic activity. Epithelioid sarcoma usually manifests as a painless firm-to-hard growth on the skin or an ulcerated superficial lesion. Patients generally do not live 5 years beyond the diagnosis. The Phase 2 studies that supported the approval showed an overall response rate of 15%, with 1.6% of patients achieving a complete response and 13% demonstrating a partial response. Among responders in the trial, 67% exhibited a duration of response of 6 months or longer. Serious adverse reactions occurred in 37% of patients. The most common serious adverse reactions were pain, fatigue, nausea, decreased appetite, vomiting and constipation. Continued approval for this indication is contingent upon findings from ongoing clinical investigations of tazemetostat to validate its therapeutic benefit.

Trade Name: Arazlo^™
Company: Ortho Dermatologics, Bausch Health

Approval Dates/Comments: The FDA approved this new preparation of tazarotene in December 2019 for the topical treatment of acne vulgaris in patients 9 years of age and older. Tazarotene lotion 0.045% is the first tazarotene acne treatment available in a lotion form, and clinical investigations demonstrated strong efficacy with favorable tolerability. The regulatory approval was based on data from two Phase 3 multicenter, randomized, double-blind, vehicle-controlled clinical trials in 1,614 patients with moderate to severe acne. In both Phase 3 studies, all primary efficacy endpoints were met with statistical significance (p<0.001). The drug was also shown to be well-tolerated in the clinical study population. In a Phase 2, head-to-head study comparing tazarotene lotion 0.045% (Arazlo™) and tazarotene cream 0.1% (Tazorac^®), the findings demonstrated similar treatment success rates and comparable reductions in both inflammatory and non-inflammatory lesions over 12 weeks. While there were no significant differences in patient satisfaction or quality of life between the two treatments and both were well-tolerated, there were twice the number of treatment-related adverse events with tazarotene cream 0.1% (5.6% with Tazorac® versus 2.9% with Arazlo™). The most frequent adverse events reported with Arazlo™ (greater than 1%) were application site pain, dryness, exfoliation, erythema and pruritus.

Trade Name: ABP 798
Company: Amgen, Allergan

Approval Dates/Comments: In December 2019, Amgen and Allergan announced the submission of a Biologics License Application (BLA) to the FDA for ABP 798, a biosimilar candidate to Rituxan^® (rituximab). Rituxan is a CD20-directed cytolytic antibody that has been approved for hematologic and autoimmune indications, including the treatment of adult patients alone or in combination with chemotherapy for non-Hodgkin’s lymphoma, in combination with fludarabine and cyclophosphamide for chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis with glucocorticoids.